Metecon
Metecon GmbH is a strategic partner for manufacturers of medical devices and IVDs, supporting them throughout the entire product lifecycle with services in technical documentation, clinical affairs, verification and validation, regulatory affairs, and quality management. The company aims to enable clients to achieve efficient market access and long-term compliance, fostering trustful relationships and continuous development. With over 20 years of experience, Metecon offers comprehensive regulatory compliance services for medical and in-vitro diagnostic devices, helping clients navigate complex regulations such as MDR and IVDR, and supporting them from product development to post-market surveillance.
Industries
Nr. of Employees
medium (51-250)
Products
Whitepaper: IVDR technical documentation guidance
A downloadable PDF guide describing differences between IVDD and IVDR, gap analysis approach, remediation planning, content requirements for technical documentation and post-market surveillance obligations.
Whitepaper: IVDR technical documentation guidance
A downloadable PDF guide describing differences between IVDD and IVDR, gap analysis approach, remediation planning, content requirements for technical documentation and post-market surveillance obligations.
Services
Drafting, reviewing and updating technical documentation and product dossiers for regulatory submissions and conformity assessment.
Services include clinical evaluation, PMCF strategy and execution, PMS system design and preparation of periodic reports.
Development of verification/validation strategies, test plans, execution documentation and reporting to demonstrate device performance.
Support for conformity assessments, notified body interactions, international registrations and IVDR transition planning.
QMS gap analysis, process implementation, audit readiness and internal audit support aligned with applicable standards.
Acting as a legally responsible person or authorized representative in EU/CH to fulfill market access and regulatory obligations.
Drafting, reviewing and updating technical documentation and product dossiers for regulatory submissions and conformity assessment.
Services include clinical evaluation, PMCF strategy and execution, PMS system design and preparation of periodic reports.
Development of verification/validation strategies, test plans, execution documentation and reporting to demonstrate device performance.
Support for conformity assessments, notified body interactions, international registrations and IVDR transition planning.
QMS gap analysis, process implementation, audit readiness and internal audit support aligned with applicable standards.
Acting as a legally responsible person or authorized representative in EU/CH to fulfill market access and regulatory obligations.
Expertise Areas
- Regulatory compliance for medical devices and in‑vitro diagnostics (MDR/IVDR)
- Technical documentation and regulatory dossier preparation
- Clinical evaluation, PMCF and post-market surveillance (PMS)
- Verification, validation and test strategy development
Key Technologies
- Regulatory information management systems
- IEC 62304-aligned software lifecycle processes
- Post-market surveillance reporting frameworks (PSUR, SSP)
- Analytical and clinical performance evaluation methodologies for diagnostics
News & Updates
Metecon welcomes Katharina Thievessen to the management, forming a strong duo for the future.
How manufacturers can handle FDA uncertainties and EU challenges with regulatory resilience.
Successful change management in quality management for medical technology.
Metecon is again awarded as 'Employer of the Year 2025'.
An article on the impact of AI and Big Data on digital diagnostics.
Guidance on the requirements for in-house IVDs under IVDR.
Metecon welcomes Katharina Thievessen to the management, forming a strong duo for the future.
How manufacturers can handle FDA uncertainties and EU challenges with regulatory resilience.
Successful change management in quality management for medical technology.
Metecon is again awarded as 'Employer of the Year 2025'.
An article on the impact of AI and Big Data on digital diagnostics.
Guidance on the requirements for in-house IVDs under IVDR.